[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623761":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":82,"collaborators":84,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":10,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":10,"maxAge":10,"enrollmentInfo":105,"targetDuration":108,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Women with postmenopausal bleeding",null,"Women referred for diagnostic evaluation to gynaecological departments for endometrial cancer due to postmenopausal bleeding",[13],"Diagnostic Test: DNA-methylation testing in patient-collected urine and vaginal samples and clinician-collected cervical samples",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","DNA-methylation testing in patient-collected urine and vaginal samples and clinician-collected cervical samples","DNA-methylation testing of methylation markers CDO1, GHSR and ZIC1 for patient-collected vaginal samples, GHSR, CDH13 and SST for patient-collected urine samples and CDH13 + CDO1 + ZIC1 for clinician-collected cervical samples.",[9],[21],{"name":22,"affiliation":23,"role":24},"Mette Tranberg, PhD","University Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Karen O. Binderup","CONTACT","+4524656562","kabind@rm.dk",{"name":22,"role":28,"phone":32,"phoneExt":10,"email":33},"+4578420264","mettrani@rm.dk",[35,53,67],{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Department of Obstetrics and Gynaecology, Aarhus University Hospital","RECRUITING","Aarhus N","8200","Denmark","DK",{"type":43,"coordinates":44},"Point",[45,46],10.17317,56.20367,{"lat":46,"lon":45},[49],{"name":50,"role":28,"phone":51,"phoneExt":10,"email":52},"Line W. Gustafson, MD, PhD","+4530714688","Line.Winther@skejby.rm.dk",{"facility":54,"status":37,"city":55,"state":10,"zip":56,"country":40,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Department of Obstetrics and Gynaecology, Odense University Hospital","Odense","5000",{"type":43,"coordinates":58},[59,60],10.38831,55.39594,{"lat":60,"lon":59},[63],{"name":64,"role":28,"phone":65,"phoneExt":10,"email":66},"Lone K. Petersen, MD, dr.med","+4530576810","Lone.Kjeld.Petersen@rsyd.dk",{"facility":68,"status":69,"city":70,"state":10,"zip":71,"country":40,"countryCode":41,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Department of Obstetrics and Gynaecology, Randers Regional Hospital","NOT_YET_RECRUITING","Randers","8930",{"type":43,"coordinates":73},[74,75],10.03639,56.4607,{"lat":75,"lon":74},[78],{"name":79,"role":28,"phone":80,"phoneExt":10,"email":81},"Isa Niemann, MD, PhD","+4521141753","isaniema@rm.dk",{"type":83,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[85,87,89,91,93,95],{"name":86,"class":6},"Central Denmark Region",{"name":88,"class":6},"University of Southern Denmark",{"name":90,"class":6},"Randers Regional Hospital",{"name":92,"class":6},"Region of Southern Denmark",{"name":94,"class":6},"Amsterdam UMC",{"name":96,"class":6},"Aarhus University Hospital","100623761","evaluation-of-dna-methylation-markers-for-endometrial-cancer-risk-stratification-using-patient-collected-urine-and-vaginal-samples-and-clinician-collected-cervical-samples-from-women-with-postmenopausal-bleeding-100623761",false,"NCT07400835","Evaluation of DNA Methylation Markers for Endometrial Cancer Risk-stratification Using Patient-collected Urine and Vaginal Samples and Clinician-collected Cervical Samples From Women With Postmenopausal Bleeding","The ENDOMETRIAL Study: EvaluatioN of DNA methylatiOn Markers for EndomeTrial Cancer Risk-stratification Using Patient-collected urIne and vAginal Samples and Clinician-collected Cervical Samples From Women With Postmenopausal bLeeding","Inclusion Criteria:\n\n* Postmenopausal bleeding (defined as vaginal bleeding after absence of periods for ≥ 12 months) undergoing diagnostic evaluation for EC at gynaecological departments\n* Treated in Central Denmark Region or Southern Denmark Region, Denmark\n* Able to provide written consent for participation\n* Able to read and understand Danish\n\nExclusion Criteria:\n\n* Other concurrent cancer diagnosis besides diagnostic evaluation for postmenopausal bleeding\n* Withdrawal of consent\n* Hysterectomized","FEMALE",{"count":106,"type":107},600,"ESTIMATED","2 Years","OBSERVATIONAL","The goal of this observational study is to investigate the clinical utility of DNA-methylation testing in urine and vaginal samples collected by patients and cervical samples collected by clinicians, to determine the risk of endometrial cancer in symptomatic women with postmenopausal bleeding. The study aims to answer the following research questions:\n\n* What is the diagnostic accuracy of DNA methylation testing in urine, vaginal and cervical samples compared to traditional TVUS for endometrial cancer detection?\n* What is the 2-year risk of EC among women testing negative on TVUS and\u002For DNA methylation tests or those testing positive on methylation only?\n\nResearchers will compare DNA methylation testing in patient-collected urine and vaginal samples as well as in clinician-collected cervical samples, with the traditional diagnostic pathway for women with PMB, which includes TVUS evaluation, and when indicated by abnormal TVUS findings, endometrial biopsy according to clinical guidelines.\n\nParticipants will\n\n* take a urine and vaginal sample\n* have a cervical sample collected by a clinician\n* undergo TVUS evaluation according to clinical guidelines\n* If TVUS shows thickened endometrium (≥ 5 mm) and\u002For irregularity, an endometrial biopsy will be collected according to clinical guidelines\n* fill out a questionnaire regarding acceptability and preferences of sampling methods and complete a lifestyle questionnaire.",[112],"Postmenopausal Bleeding",[114,115,116,117,118,119],"DNA methylation","Postmenopausal bleeding","Endometrial Cancer","Patient-collected urine samples","cervical samples","Patient-collected vaginal samples","2026-05-12",{"date":122,"type":123},"2026-05-13","ACTUAL",{"date":125,"type":123},"2026-02-24",{"date":127,"type":107},"2030-02-24",{"name":5,"class":6},3]